Metformin Hydrochloride
These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
4d89a4ab-6cdd-4c39-92f9-a137fa27a070
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 2, 2021
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metformin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71610-533
Application NumberANDA078321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2021
FDA Product Classification
INGREDIENTS (6)
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
carboxymethylcellulose sodium, unspecified formInactive
Code: K679OBS311
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Metformin HydrochlorideActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT